MEDICAL DEVICE PRODUCT DEVELOPMENT | ISO 13485 QUALITY SYSTEM | OEM / ODM
Portable Medical Device Components

Portable Medical Devices
Metal & Plastic Parts
Production & Assembly

From design drawings, materials and process conditions to dimensional measurement, first article approval and outgoing inspection, PROCH translates engineering requirements into manufacturable, inspectable and traceable production specifications.

Design Data Integration2D/3D, BOM, CTQ and revision control
Process & Assembly IntroductionCNC, injection molding, tooling and assembly conditions
Measurement & QualityFAI, in-process, outgoing and lot traceability
ISO 13485Medical device quality management system
ISO 9001:2015Quality management system
OEM / ODMConfigured to project maturity
Design to ManufacturingIntegrated product realization
What Customers Ask First

Three priorities customers care about. Clear answers from PROCH

From supplier screening to technical evaluation, these questions often determine whether a project should move forward.

METAL + PLASTIC|PRODUCTIONCan you integrate metal and plastic components from prototype to production?

Yes. PROCH integrates CNC machining, mold development, plastic injection molding, surface treatment coordination, inspection and assembly, with support defined for drawings, samples, pilot builds and controlled production.

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QUALITY EVIDENCE|TRACEABILITYWhat quality and inspection evidence supports supplier evaluation?

Operations are supported by ISO 9001 and ISO 13485 quality systems. FAI, in-process and outgoing inspection, process capability and lot traceability can be planned to agreed requirements.

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RFQ|NDAWhat do you need for an RFQ, and how are confidential drawings protected?

Prepare 2D/3D files, material, quantity, finish, critical dimensions, samples and schedule. An NDA can be completed before full technical files are exchanged.

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